DuoCAR20.19.22-D95 for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen byJoseph McGuirk, D.O.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Kansas Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This multicenter phase 1 trial with "3 + 3" dose escalation design seeks to examine the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of chimeric antigen receptors targeting the B cell surface antigens CD19/20/22 following administration of a chemotherapy lymphodepletion regimen in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) or Non-Hodgkin's lymphoma (NHL). The overall goals of this study are to estimate maximum tolerated dose (MTD) level, establish the overall safety profile and evaluate initial efficacy of administering duo-CAR-T cell treatment in this patient population.

Eligibility Criteria

Adults with B-cell malignancies that have come back or didn't respond to treatment can join. They must be fit for chemotherapy and T cell modification therapy. People are excluded if they've had certain treatments recently, have active infections, or other serious health issues.

Inclusion Criteria

My cancer is a type of aggressive B-Cell NHL or ALL.

I am eligible for or have had a leukapheresis procedure.

Ability of participant to understand this study, and participant willingness to sign a written informed consent

+12 more

Exclusion Criteria

I currently have COVID-19.

I haven't had chemotherapy other than for immune preparation in the last 2 weeks.

I have not had radiation therapy in the last 2 weeks.

+17 more

Participant Groups

The trial tests a new therapy called DuoCAR20.19.22-D95 on patients who've relapsed from B-cell lymphoma or leukemia. It involves modifying the patient's own T cells after chemo to see how well it works and what dose is safe.

1Treatment groups

Experimental Treatment

Group I: Phase 1 (Dose Escalation)Experimental Treatment3 Interventions

Lymphodepletion: Fludarabine: Days -6 to -3 (4 days total) Cyclophosphamide: Days -4 and -3 (2 days total) Investigational Treatment: DuoCAR20.19.22-D95 will be infused on day # 0 Patients will receive lymphodepletion chemotherapy and receive the CAR T cell infusion on day 0 (or up to day +14 in extenuating clinical conditions). Patients will be hospitalized inpatient period of at least 7 days from the day of the CAR T infusion.